(63 days)
Pulpdent Post Cement is a fluoride releasing, dual cure dental resin cement that contains no Bisphenol A. It is used to permanently cement dental posts, porcelain crowns, inlays, onlays, bridges, veneers, and periodontal splints to tooth structure. Pulpdent Post Cement is also used for bonded amalgam techniques.
PULPDENT POST CEMENT is a fluoride releasing, dual cure dental resin cement that contains no Bisphenol A. It is used to permanently cement dental posts, porcelain crowns, inlays, onlays, bridges, veneers and periodontal splints to tooth structure. Pulpdent Post Cement is also used for bonded amalgam techniques.
This submission describes a 510(k) premarket notification for a dental cement (Pulpdent Post Cement), not an AI/ML device. Therefore, the request for information on acceptance criteria, study details, ground truth, and training sets, which are relevant for AI/ML device evaluations, cannot be fulfilled from the provided text.
The document indicates that the Pulpdent Post Cement is claiming substantial equivalence to predicate devices based on design, composition, performance, intended use, safety, and effectiveness. The "Safety and Effectiveness" section explicitly states that the device is substantially equivalent to established predicate products. This means that instead of conducting a new study with acceptance criteria, the manufacturer is asserting that their new device is as safe and effective as devices already on the market, avoiding the need for a de novo marketing authorization or premarket approval.
The submission includes:
- Device Name: PULPDENT POST CEMENT
- Classification Name: Dental Cement
- FDA Product Code: 76 EMA, 21 CFR Part 872.3275
- Predicate Devices: Pulpdent ResiLute, Kuraray / J. Morita Panavia F, ESPE Compolute Aplicap, Ivoclar / Vivadent Variolink II
- Description and Intended Use: A fluoride-releasing, dual-cure dental resin cement used for permanently cementing dental posts, crowns, inlays, onlays, bridges, veneers, periodontal splints, and for bonded amalgam techniques.
- Comparison with Predicate Products: Stated as substantially equivalent in design, composition, performance, intended use, safety, and effectiveness.
- Safety and Effectiveness: Relies on the substantial equivalence to predicate products and general usage history of similar dental materials, noting a "high benefit-to-risk ratio" and "no evidence of short-term or long-term risk" based on a NIH Technology Assessment Conference for composites and glass ionomers.
None of the requested information regarding AI/ML device evaluations can be extracted from this 510(k) submission.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.